NCT06164210 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Anderson K, Bird M, Macpherson S, McDonough V, Davis T
Findings from a pilot investigation of the effectiveness of a snoezelen room in residential care: should we be engaging with our residents more? Geriatr Nurs. 2011 May-Jun;32(3):166-77. doi: 10.1016/j.gerinurse.2010.12.011. Epub 2011 Feb 9.
Bishir M, Bhat A, Essa MM, Ekpo O, Ihunwo AO, Veeraraghavan VP, Mohan SK, Mahalakshmi AM, Ray B, Tuladhar S, Chang S, Chidambaram SB, Sakharkar MK, Guillemin GJ, Qoronfleh MW, Ojcius DM
Sleep Deprivation and Neurological Disorders. Biomed Res Int. 2020 Nov 23;2020:5764017. doi: 10.1155/2020/5764017. eCollection 2020.
Krakowiak P, Goodlin-Jones B, Hertz-Picciotto I, Croen LA, Hansen RL
Sleep problems in children with autism spectrum disorders, developmental delays, and typical development: a population-based study. J Sleep Res. 2008 Jun;17(2):197-206. doi: 10.1111/j.1365-2869.2008.00650.x. Erratum In: J Sleep Res. 2012 Apr;21(2):231.
Mazurek MO, Sohl K
Sleep and Behavioral Problems in Children with Autism Spectrum Disorder. J Autism Dev Disord. 2016 Jun;46(6):1906-1915. doi: 10.1007/s10803-016-2723-7.
Reynolds AM, Malow BA
Sleep and autism spectrum disorders. Pediatr Clin North Am. 2011 Jun;58(3):685-98. doi: 10.1016/j.pcl.2011.03.009.
Sullivan GM, Feinn R
Using Effect Size-or Why the P Value Is Not Enough. J Grad Med Educ. 2012 Sep;4(3):279-82. doi: 10.4300/JGME-D-12-00156.1. No abstract available.

Investigation of the Effect of Snoezelen-Based Occupational Therapy Intervention on Sleep and Behavioral Problems in 18-36 Months Children at Risk of Autism

Details for clinical trial NCT06164210

Clinical trial NCT06164210 - References